De-escalation of Postoperative Radiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma With Pathological Complete Response/Major Pathological Response: A Single-arm, Prospective Phase II Clinical Study

Fifth Affiliated Hospital, Sun Yat-Sen University1 site in 1 country23 target enrollmentApril 10, 2023

ConditionsHead and Neck Squamous Cell Carcinoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Head and Neck Squamous Cell Carcinoma
Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
Enrollment: 23
Locations: 1
Primary Endpoint: Disease Free Survival (DFS)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open-label, single-arm, phase II clinical trial to explore the efficacy and safety of de-escalation of postoperative radiotherapy in locally advanced head and neck squamous cell carcinoma with pathological complete response/major pathological response to neoadjuvant therapy. The eligible patients are scheduled to administered postoperative radiotherapy, PTV 50Gy/25F, instead of the standard dose of 60Gy. The overall primary study hypothesis is that reducing the dose of postoperative radiotherapy in the specific population does not affect DFS but significantly reduces treatment related adverse events.

Registry

clinicaltrials.gov

Start Date

April 10, 2023

End Date

April 9, 2027

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University

Responsible Party

Principal Investigator

Yingpeng Peng

Director

Fifth Affiliated Hospital, Sun Yat-Sen University

Eligibility Criteria

Inclusion Criteria

•Untreated, histologically confirmed head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx or larynx), staging T3-4N0M0 or T1-4N1-3M0, III-IVB, according to the eighth edition of the AJCC staging system; within 6 weeks after receiving neoadjuvant therapy and radical surgery.
•Pathological evaluation of surgical specimens was pCR (pathologic complete response, no viable tumor cells) or MPR (Major pathologic response, residual viable tumor cells≤10%).
•Negative surgical margin.
•No extranodal extension.
•Aged ≥ 18 years and ≤ 70 years.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
•Life expectancy of more than 6 months.
•Adequate organ function, based on meeting all of the following criteria (no blood components and cytologic growth factors were received within 14 days prior to the test):
•Hemoglobin ≥ 75 g/L; absolute neutrophil count ≥ 1.5 × 10\^9/L; and platelet count ≥ 100 × 10\^9/L;
•Serum albumin ≥ 25 g/L;

Exclusion Criteria

•Pregnant or lactating women.
•A history of other malignant tumors within the previous 5 years or at the time of enrollment, except for cured skin basal cell carcinoma and cervical in situ cancer, as well as thyroid papilloma.
•Neoadjuvant therapy or radical surgery was not completed.
•Recurrence or distant metastasis occurred before postoperative radiotherapy.
•There are contraindications for radiotherapy, chemotherapy, immunotherapy and targeted therapy.
•Uncontrolled cardiac clinical symptoms or diseases.
•Serious infections.
•A history of immunodeficiency, including HIV-positive status or other acquired congenital immunodeficiency diseases, or a history of organ transplantation and bone marrow transplantation.
•Patients with active tuberculosis infection found by history or CT examination, or patients with active tuberculosis infection history within 1 year prior to enrollment, or patients with active tuberculosis infection history before 1 year without formal treatment.
•Active hepatitis B (HBV DNA ≥ 2,000 IU/mL or 10,000 copies/mL) or hepatitis C (positive HCV antibody test and HCV RNA above the lower limit of detection).

Outcomes

Primary Outcomes

Disease Free Survival (DFS)

Time Frame: from the first day of treatment to the follow up of 2 years

2-year disease free survival rate

Secondary Outcomes

Overall Survival (OS)(from the first day of treatment to the follow up of 2 years)
EORTC QLQ-C30(from 1 week before treatment to the follow up of 2 years)
EORTC HN35(from 1 week before treatment to the follow up of 2 years)
Local Relapse Free Survival (LRFS)(from the first day of treatment to the follow up of 2 years)
Distant Metastasis Free Survival (DMFS)(from the first day of treatment to the follow up of 2 years)
RTOG/EORTC late radiation morbidity scoring scheme(from 1 week before treatment to the follow up of 2 years)